Tissue fixation assembly having prepositioned fasteners and method

ABSTRACT

A tissue fastener assembly delivers a fastener for deployment. The assembly includes a fastener including a first member, a second member, the first and second members having first and second ends, and a flexible connecting member fixed to each of the first and second members intermediate the first and second ends and extending between the first and second members. The first member has a longitudinal axis and a through channel along the axis. The assembly further includes a deployment wire slidingly received within the through channel of the first member that pierces into the tissue and guides the first member through the tissue, a guide structure defining a lumen that receives the fastener and deployment wire and guides the deployment wire and fastener to the tissue, and a fastener configuration structure that orientates the second member in a predetermined position relative to the first member within the lumen for dependable deployment.

RELATED APPLICATION DATA

The present patent application is a continuation-in-part application ofU.S. patent application Ser. No. 10/783,717, filed Feb. 20, 2004.

FIELD OF THE INVENTION

The present invention generally relates to tissue fixation devices, andmore particularly to assemblies for deploying the same. The presentinvention more particularly relates to such assemblies wherein tissuefixation fasteners are prepositioned for reliable deployment.

BACKGROUND

Gastroesophageal reflux disease (GERD) is a chronic condition caused bythe failure of the anti-reflux barrier located at the gastroesophagealjunction to keep the contents of the stomach from splashing into theesophagus. The splashing is known as gastroesophageal reflux. Thestomach acid is designed to digest meat, and will digest esophagealtissue when persistently splashed into the esophagus.

A principal reason for regurgitation associated with GERD is themechanical failure of a deteriorated gastroesophageal flap to close andseal against high pressure in the stomach. Due to reasons includinglifestyle, a Grade I normal gastroesophageal flap may deteriorate into amalfunctioning Grade III or absent valve Grade IV gastroesophageal flap.With a deteriorated gastroesophageal flap, the stomach contents are morelikely to be regurgitated into the esophagus, the mouth, and even thelungs. The regurgitation is referred to as “heartburn” because the mostcommon symptom is a burning discomfort in the chest under thebreastbone. Burning discomfort in the chest and regurgitation (burpingup) of sour-tasting gastric juice into the mouth are classic symptoms ofgastroesophageal reflux disease (GERD). When stomach acid isregurgitated into the esophagus, it is usually cleared quickly byesophageal contractions. Heartburn (backwashing of stomach acid and bileonto the esophagus) results when stomach acid is frequently regurgitatedinto the esophagus and the esophageal wall is inflamed.

Complications develop for some people who have GERD. Esophagitis(inflammation of the esophagus) with erosions and ulcerations (breaks inthe lining of the esophagus) can occur from repeated and prolonged acidexposure. If these breaks are deep, bleeding or scarring of theesophagus with formation of a stricture (narrowing of the esophagus) canoccur. If the esophagus narrows significantly, then food sticks in theesophagus and the symptom is known as dysphagia. GERD has been shown tobe one of the most important risk factors for the development ofesophageal adenocarcinoma. In a subset of people who have severe GERD,if acid exposure continues, the injured squamous lining is replaced by aprecancerous lining (called Barrett's Esophagus) in which a cancerousesophageal adenocarcinoma can develop.

Other complications of GERD may not appear to be related to esophagealdisease at all. Some people with GERD may develop recurrent pneumonia(lung infection), asthma (wheezing), or a chronic cough from acidbacking up into the esophagus and all the way up through the upperesophageal sphincter into the lungs. In many instances, this occurs atnight, while the person is in a supine position and sleeping.Occasionally, a person with severe GERD will be awakened from sleep witha choking sensation. Hoarseness can also occur due to acid reaching thevocal cords, causing a chronic inflammation or injury.

GERD never improves without intervention. Life style changes combinedwith both medical and surgical treatments exist for GERD. Medicaltherapies include antacids and proton pump inhibitors. However, themedical therapies only mask the reflux. Patients still get reflux andperhaps emphysema because of particles refluxed into the lungs.Barrett's esophagus results in about 10% of the GERD cases. Theesophageal epithelium changes into tissue that tends to become cancerousfrom repeated acid washing despite the medication.

Several open laparotomy and laproscopic surgical procedures areavailable for treating GERD. One surgical approach is the Nissenfundoplication. The Nissen approach typically involves a 360-degree wrapof the fundus around the gastroesophageal junction. The procedure has ahigh incidence of postoperative complications. The Nissen approachcreates a 360-degree moveable flap without a fixed portion. Hence,Nissen does not restore the normal movable flap. The patient cannot burpbecause the fundus was used to make the repair, and may frequentlyexperience dysphagia. Another surgical approach to treating GERD is theBelsey Mark IV (Belsey) fundoplication. The Belsey procedure involvescreating a valve by suturing a portion of the stomach to an anteriorsurface of the esophagus. It reduces some of the postoperativecomplications encountered with the Nissen fundoplication, but still doesnot restore the normal movable flap. None of these procedures fullyrestores the normal anatomical anatomy or produces a normallyfunctioning gastroesophageal junction. Another surgical approach is theHill repair. In the Hill repair, the gastroesophageal junction isanchored to the posterior abdominal areas, and a 180-degree valve iscreated by a system of sutures. The Hill procedure restores the moveableflap, the cardiac notch and the Angle of His. However, all of thesesurgical procedures are very invasive, regardless of whether done as alaproscopic or an open procedure.

New, less surgically invasive approaches to treating GERD involvetransoral endoscopic procedures. One procedure contemplates a machinedevice with robotic arms that is inserted transorally into the stomach.While observing through an endoscope, an endoscopist guides the machinewithin the stomach to engage a portion of the fundus with acorkscrew-like device on one arm. The arm then pulls on the engagedportion to create a fold of tissue or radial plication at thegastroesophageal junction. Another arm of the machine pinches the excesstissue together and fastens the excess tissue with one pre-tied implant.This procedure does not restore normal anatomy. The fold created doesnot have anything in common with a valve. In fact, the direction of theradial fold prevents the fold or plication from acting as a flap of avalve.

Another transoral procedure contemplates making a fold of fundus tissuenear the deteriorated gastroesophageal flap to recreate the loweresophageal sphincter (LES). The procedure requires placing multipleU-shaped tissue clips around the folded fundus to hold it in shape andin place.

This and the previously discussed procedure are both highly dependent onthe skill, experience, aggressiveness, and courage of the endoscopist.In addition, these and other procedures may involve esophageal tissue inthe repair. Esophageal tissue is fragile and weak. Involvement ofesophageal tissue in the repair of a gastroesophageal flap valve posesunnecessary risks to the patient.

A new and improved apparatus and method for restoration of agastroesophageal flap valve is fully disclosed in U.S. Pat. No.6,790,214, is assigned to the assignee of this invention, and isincorporated herein by reference. That apparatus and method provides atransoral endoscopic gastroesophageal flap valve restoration. Alongitudinal member arranged for transoral placement into a stomachcarries a tissue shaper that non-invasively grips and shapes stomachtissue. A tissue fixation device is then deployed to maintain the shapedstomach tissue in a shape approximating and restoring a gastroesophagealflap.

Whenever tissue is to be maintained in a shape as, for example, in theimproved assembly last mentioned above, it is necessary to fasten atleast two layers of tissue together. In applications such asgastroesophageal flap valve restoration, there is very limited room tomaneuver a fastener deployment device. For example, this and othermedical fastening applications provide confined working channels andspaces and often must be fed through an endoscope to permitvisualization or other small lumen guide catheters to the place wherethe fasteners are to be deployed. To make matters worse, multiplefasteners may also be required. Hence, with current fasteners anddeployment arrangements, it is often difficult to direct a singlefastener to its intended location, let alone a number of such fasteners.

Once the fastening site is located, the fasteners employed must be trulyable to securely maintain the tissue. Also, quite obviously, thefasteners are preferably deployable in the tissue in a manner which doesnot unduly traumatize the tissue. Moreover, the fasteners and deploymentassemblies must assure dependable operation to negate the need forrepeated deployment attempts.

SUMMARY

The invention provides a fastener assembly comprising a fastenerincluding a first member, a second member, the first and second membershaving first and second ends, and a flexible connecting member fixed toeach of the first and second members intermediate the first and secondends and extending between the first and second members. The firstmember has a longitudinal axis and a through channel along the axis. Theassembly further comprises a deployment wire slidingly received withinthe through channel of the first member that pierces into the tissue andguides the first member through the tissue, a guide structure defining alumen that receives the fastener and deployment wire and guides thedeployment wire and fastener to the tissue, and a fastener configurationstructure that orientates the second member in a predetermined positionrelative to the first member within the lumen.

The fastener configuration structure orientates the second member alongside the first member. The fastener configuration structure orientatesthe second member along side the first member with the connecting memberbetween the first and second members. The fastener configurationstructure orientates the second member along side the first member withthe connecting member between the first and second members and with thesecond member trailing the first member with respect to the tissue.

The first member of the fastener may have a lengthwise slitcommunicating with the through channel and the deployment wire may bereceived into the through channel through the slit.

The assembly may further comprise a fastener loader that guides thefirst member slit into engagement with the deployment wire. The fastenerloader is preferably arranged to hold a plurality of the fasteners. Thefastener configuration structure may comprise a wall converging with thedeployment wire and an outlet communicating with the lumen. The wallpreferably converges with the deployment wire in a direction towards thetissue so that, when the second member engages the wall, the walldirects the second member to the predetermined position relative to thefirst member. The wall thus orientates the second member along side thefirst member.

The invention further provides a fastener assembly comprising a fastenerincluding a first member, a second member, the first and second membershaving first and second ends, and a flexible connecting member fixed toeach of the first and second members intermediate the first and secondends and extending between the first and second members. The firstmember has a longitudinal axis and a through channel along the axis. Theassembly further comprises a deployment wire slidingly received withinthe through channel of the first member that pierces into the tissue andguides the first member through the tissue, and a guide structuredefining a lumen that receives the fastener and deployment wire andguides the deployment wire and fastener to the tissue. The second memberof the fastener is along side the first member with the connectingmember between the first and second members within the lumen.

The invention still further provides a method comprising providing afastener including a first member, a second member, the first and secondmembers having first and second ends, and a flexible connecting memberfixed to each of the first and second members intermediate the first andsecond ends and extending between the first and second members. Thefirst member has a longitudinal axis and a through channel along theaxis. The method further comprises mounting the fastener onto adeployment wire with the deployment wire slidingly received by thethrough channel of the first member, translating the fastener to withina lumen dimensioned to receive the fastener and deployment wire andwhich guides the deployment wire and fastener to tissue, and orientatingthe second member in a predetermined position relative to the firstmember as the fastener is translated to within the lumen.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further objects and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like referenced numerals identify like elements, and wherein:

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract from a lower portion of the esophagusto the duodenum;

FIG. 2 is a front cross-sectional view of theesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap of the gastroesophageal flap valve (in dashedlines) and a Grade III reflux appearance gastroesophageal flap of thegastroesophageal flap valve (in solid lines);

FIG. 3 is a perspective view of a fastener according to an embodiment ofthe invention;

FIG. 4 is a perspective view of another fastener according to anembodiment of the invention;

FIG. 5 is a perspective view with portions cut away of a fastenerassembly according to an embodiment of the invention with the fastenerprepositioned according to this embodiment and in an early stage ofdeployment;

FIG. 6 is a perspective view of the assembly of FIG. 5 shown with thefastener being driven in the tissue layers to be fastened;

FIG. 7 is a perspective view of the assembly of FIG. 5 shown with thefastener extending through the tissue layers to be fastened;

FIG. 8 is a perspective view of the assembly of FIG. 5 shown with thefastener initially deployed;

FIG. 9 is a perspective view showing the fastener of the assembly ofFIG. 5 fully deployed and securely fastening a pair of tissue layerstogether;

FIG. 10 is a perspective view of a further fastener embodying theinvention;

FIG. 11 is a side view of the fastener of FIG. 10;

FIG. 12 is a perspective view with portions cut away of a fastenerassembly according to another embodiment of the invention with thefastener prepositioned and in an early stage of being deployed;

FIG. 13 is a perspective view of the assembly of FIG. 12 shown with thefastener being driven in the tissue layers to be fastened;

FIG. 14 is a perspective view of the assembly of FIG. 12 shown with thefastener in an intermediate stage of deployment;

FIG. 15 is a perspective view of the assembly of FIG. 12 shown with thefastener almost completely deployed;

FIG. 16 is a perspective view showing the fastener of the assembly ofFIG. 5 fully deployed;

FIG. 17 is a perspective view of a fastener assembly according to anembodiment of the invention;

FIG. 18 is a perspective view, with portions cut away, of the assemblyof FIG. 18 showing a fastener being driven into a fastener configurationstructure according to an embodiment of the invention;

FIG. 19 is a simplified side view, partly in section, of the fastenerconfiguration structure of FIG. 19; and

FIG. 20 is a perspective view of the assembly of FIGS. 18 and 19 alongwith a fastener loader according to an embodiment of the invention forloading fasteners into the deployment assembly.

DETAILED DESCRIPTION

FIG. 1 is a front cross-sectional view of theesophageal-gastro-intestinal tract 40 from a lower portion of theesophagus 41 to the duodenum 42. The stomach 43 is characterized by thegreater curvature 44 on the anatomical left side and the lessercurvature 45 on the anatomical right side. The tissue of the outersurfaces of those curvatures is referred to in the art as serosa tissue.As will be seen subsequently, the nature of the serosa tissue is used toadvantage for its ability to bond to like serosa tissue. The fundus 46of the greater curvature 44 forms the superior portion of the stomach43, and traps gas and air bubbles for burping. The esophageal tract 41enters the stomach 43 at an esophageal orifice below the superiorportion of the fundus 46, forming a cardiac notch 47 and an acute anglewith respect to the fundus 46 known as the Angle of His 57. The loweresophageal sphincter (LES) 48 is a discriminating sphincter able todistinguish between burping gas, liquids, and solids, and works inconjunction with the fundus 46 to burp. The gastroesophageal flap valve(GEFV) 49 includes a moveable portion and an opposing more stationaryportion. The moveable portion of the GEFV 49 is an approximately 180degree, semicircular, gastroesophageal flap 50 (alternatively referredto as a “normal moveable flap” or “moveable flap”) formed of tissue atthe intersection between the esophagus 41 and the stomach 43. Theopposing more stationary portion of the GEFV 49 comprises a portion ofthe lesser curvature 45 of the stomach 43 adjacent to its junction withthe esophagus 41. The gastroesophageal flap 50 of the GEFV 49principally comprises tissue adjacent to the fundus 46 portion of thestomach 43, is about 4 to 5 cm long (51) at it longest portion, and thelength may taper at its anterior and posterior ends. Thegastroesophageal flap 50 is partially held against the lesser curvature45 portion of the stomach 43 by the pressure differential between thestomach 43 and the thorax, and partially by the resiliency and theanatomical structure of the GEFV 49, thus providing the valvingfunction. The GEFV 49 is similar to a flutter valve, with thegastroesophageal flap 50 being flexible and closeable against the othermore stationary side.

The esophageal tract is controlled by an upper esophageal sphincter(UES) in the neck near the mouth for swallowing, and by the LES 48 andthe GEFV 49 at the stomach. The normal anti-reflux barrier is primarilyformed by the LES 48 and the GEFV 49 acting in concert to allow food andliquid to enter the stomach, and to considerably resist reflux ofstomach contents into the esophagus 41 past the gastroesophageal tissuejunction 52. Tissue aboral of the gastroesophageal tissue junction 52 isgenerally considered part of the stomach because the tissue protectedfrom stomach acid by its own protective mechanisms. Tissue oral of thegastroesophageal junction 52 is generally considered part of theesophagus and it is not protected from injury by prolonged exposure tostomach acid. At the gastroesophageal junction 52, the juncture of thestomach and esophageal tissues form a zigzag line, which is sometimesreferred to as the “Z-line.” For the purposes of these specifications,including the claims, “stomach” means the tissue aboral of thegastroesophageal junction 52.

FIG. 2 is a front cross-sectional view of anesophageal-gastro-intestinal tract illustrating a Grade I normalappearance movable flap 50 of the GEFV 49 (shown in dashed lines) and adeteriorated Grade III gastroesophageal flap 55 of the GEFV 49 (shown insolid lines). As previously mentioned, a principal reason forregurgitation associated with GERD is the mechanical failure of thedeteriorated (or reflux appearance) gastroesophageal flap 55 of the GEFV49 to close and seal against the higher pressure in the stomach. Due toreasons including lifestyle, a Grade I normal gastroesophageal flap 50of the GEFV 49 may deteriorate into a Grade III deterioratedgastroesophageal flap 55. The anatomical results of the deteriorationinclude moving a portion of the esophagus 41 that includes thegastroesophageal junction 52 and LES 48 toward the mouth, straighteningof the cardiac notch 47, and increasing the Angle of His 57. Thiseffectively reshapes the anatomy aboral of the gastroesophageal junction52 and forms a flattened fundus 56. The deteriorated gastroesophagealflap 55 illustrates a gastroesophageal flap valve 49 and cardiac notch47 that have both significantly degraded. Dr. Hill and colleaguesdeveloped a grading system to describe the appearance of the GEFV andthe likelihood that a patient will experience chronic acid reflux. L. D.Hill, et al., The gastroesophageal flap valve: in vitro and in vivoobservations, Gastrointestinal Endoscopy 1996:44:541-547. Under Dr.Hill's grading system, the normal movable flap 50 of the GEFV 49illustrates a Grade I flap valve that is the least likely to experiencereflux. The deteriorated gastroesophageal flap 55 of the GEFV 49illustrates a Grade III (almost Grade IV) flap valve. A Grade IV flapvalve is the most likely to experience reflux. Grades II and III reflectintermediate grades of deterioration and, as in the case of III, a highlikelihood of experiencing reflux. With the deteriorated GEFVrepresented by deteriorated gastroesophageal flap 55 and the fundus 46moved inferior, the stomach contents are presented a funnel-like openingdirecting the contents into the esophagus 41 and the greatest likelihoodof experiencing reflux. Disclosed subsequently is a device for restoringthe normal gastroesophageal flap valve anatomy, which device is oneembodiment of the present invention.

Referring now to FIG. 3, it is a perspective view of a fastener 100according to an embodiment of the invention. The fastener 100 generallyincludes a first member 102, a second member 104, and a connectingmember 106. As may be noted in FIG. 3, the first member 102 and secondmember 104 are substantially parallel and substantially perpendicular tothe connecting member 106 which connects the first member 102 to thesecond member 104.

The first and second members 102 and 104 are generally cylindrical. Eachhas a longitudinal axis 108 and 110 and a through channel 112 and 114along the longitudinal axes 108 and 110. The through channels 112 and114 are formed by through bores which are dimensioned to be slidinglyreceived on a tissue piercing deployment wire to be describedhereinafter.

The first member 102 also includes a first end 116 and a second end 118.Similarly, the second member 114 includes a first end 120 and a secondend 122. The first ends 116 and 120 form pointed dilation tips 124 and126, respectively. The dilation tips 124 and 126 are conical and moreparticularly take the shape of truncated cones. The pointed tips 129 and126 are pointed in opposite directions.

The first and second members 102 and 104 and the connecting 106 may beformed of different materials and have different textures. Thesematerials may include, for example, plastic materials such aspolypropylene, polyethylene, polyglycolic acid, polyurethane, or athermoplastic elastomer. As may be further noted in FIG. 3, theconnecting member 106 has a vertical dimension 128 and a horizontaldimension 130 which is transverse to the vertical dimension. Thehorizontal dimension is substantially less than the vertical dimensionto render the connecting member 106 readily bendable in a horizontalplane. The connecting member is further rendered bendable by the natureof the plastic material from which the fastener 100 is formed. Theconnecting member may be formed from either an elastic plastic or apermanently deformable plastic. An elastic material would preventcompression necrosis in some applications.

Referring now to FIG. 4, it illustrates another fastener 140 embodyingthe present invention. As with the fastener 100 of FIG. 3, the fastener140 includes a first member 142, a second member 144, and a connectingmember 146. The fastener 140 may be formed in one piece and a plasticmaterial similar to the fastener 100 of FIG. 3. The fasteners 100 and140 may be formed of a plastic material which includes a color pigment,for example pthalocyanine blue, for contrasting with the color of bodytissue to enable visualization of the fastener with an endoscope duringthe deployment of the fasteners. In addition, as may be seen in FIG. 4,the fastener 140 is impregnated with radio opaque material 148 so as torender the fastener 140 at least partially viewable under fluoroscopy.The radio opaque particles may be, for example, barium sulfate, bismuthsubcarbonate, tungsten powder or tantalum powder.

In addition to the foregoing, the second member 144 of the fastener 140includes a plurality of longitudinally spaced vertical slots 150. Thisrenders the second member 144 flexible in a direction opposite the slotsbut stiff in a direction of the slots. Hence, the second member 144 isresistant to bending in a first direction indicated by arrow 152 whilebeing substantially less resistant to bending in a direction indicatedby arrow 154. The reduced resistance to bending in the direction 154 ofthe second member 144 of the fastener 140 may be utilized to advantagein the deployment of the fastener 140.

Referring now to FIG. 5, it is a perspective view with portions cut awayof a fastener assembly embodying the present invention. The tissue layerportions above the fastener 162 have been shown cut away in FIGS. 5-9 toenable the deployment procedure to be seen more clearly. The assembly160 generally includes a fastener 162, a deployment wire 164, a pusher166, and a guide tube 168.

The fastener 162 takes the form of a further fastener embodiment of thepresent invention and includes a first member 172, a second member 174,and a connecting member 176. The fastener 162 differs from the fasteners100 and 140 of FIGS. 3 and 4, respectively, in that the second member174 is of solid construction and does not include a longitudinal throughchannel or a pointed tip. However, the first member 172 includes athrough channel as previously described and a pointed tip 175.

The first member 172 of the fastener 162 is slidingly received on thedeployment wire 164. The deployment wire 164 has a pointed tip 178 forpiercing the tissue layers 180 and 182 to be fastened together. As willbe seen hereinafter, and in accordance with further aspects of thepresent invention, the tissue layers 180 and 182 may be folded stomachtissue which are to be fastened and maintained together to form andmaintain a gastroesophageal flap valve.

As will be noted in FIG. 5, the tissue piercing wire 164, fastener 162,and the pusher 166 are all within the guide tube 168. The guide tube 168may take the form of a lumen within most any lumen providing structuresuch as a catheter, for example.

As will be further noted in FIG. 5, and according to this embodiment ofthe present invention, the second member 174 is disposed along side thefirst member 172. This is rendered possible by the flexibility of theconnecting member 176. Preferably, the first member, connecting member,and second member are arranged so that the connecting member 176 liesbetween the first member 172 and the second member 174 and, asillustrated, with the second member 174 trailing the first member 172with respect to the tissue layers 180 and 182.

With the first member 172 of the fastener 162 slidingly received on thetissue piercing wire 164 and with the pusher 166 just touching the firstmember 172 on the tissue piercing wire 164, the tip 178 of the tissuepiercing wire 164 pierces the tissue layers 180 and 182. The subassemblyof the tissue piercing wire 164, fastener 162, and pusher 166 may beguided to its intended location relative to the tissue layers 180 and182 by the guide tube 168.

Once the tissue piercing wire 164 has pierced the tissue layers 180 and182 to be fastened together, the pusher 166 may be utilized to push thefirst member 172 of the fastener 162 through the tissue layers 180 and182 on the tissue piercing wire 164. This is illustrated in FIG. 6. Asthe pusher 166 pushes the first member 172 through the tissue layers 180and 182, the connecting member 176 follows along beside and immediatelyadjacent to the first member 172 of the fastener 162 and the pusher 166.As may be seen in FIG. 7, the pusher 166 continues to push the firstmember 172 of the fastener 162 through the tissue layers 180 and 182 onthe tissue piercing wire 164 until the end 173 of the first member 172engaging the pusher 166 clears the second tissue layer 182. It may alsobe noted that at this time, the second member 174 of the fastener 162has engaged the surface 181 of tissue layer 180.

Referring now to FIG. 8, it will be seen that once the end 173 of thefirst member 172 has cleared the tissue layer 182, the tissue piercingwire 164 is then retracted within the pusher 166 to release the firstmember 172. The first member 172 being thus released from the tissuepiercing wire 164 will return to its original configurationsubstantially parallel to the second member 174 and substantiallyperpendicular to the connecting member 176. When the first member 172 isdeployed as shown in FIG. 8, the tissue piercing wire 164 and pusher 166may be withdrawn.

FIG. 9 illustrates the fastener 162 in its deployed position. It will benoted that the tissue layers 180 and 182 are fastened together betweenthe first member 172 of the fastener 162 and the second member 174 ofthe fastener 162. The connecting member 176 extends through the tissuelayers 180 and 182.

FIG. 10 is a perspective view and FIG. 11 is a side view of anotherfastener 200 embodying the present invention. The fastener 200 generallyincludes a first member 202, a second member 204, and a connectingmember 206. As may be noted in FIG. 10, the first member 202 and secondmember 204 are substantially parallel to each other and substantiallyperpendicular to the connecting member 206 which connects the firstmember 202 to the second member 204.

The first member 202 is generally cylindrical or can have any othershape. It has a longitudinal axis 208 and a through channel 212 alongthe longitudinal axis 208. The through channel 212 is formed by athrough bore which is dimensioned to be slidingly received on a tissuepiercing deployment wire to be described.

The first member 202 also includes a first end 216 and a second end 218.Similarly, the second member 204 includes a first end 220 and a secondend 222. The first end 216 of member 202 forms a pointed dilation tip224. The dilation tip 224 may be conical and more particularly takes theshape of a truncated cone. The tip can also be shaped to have a cuttingedge in order to reduce tissue resistance.

The first and second members 202 and 204 and the connecting member 206may be formed of different materials and have different textures. Thesematerials may include, for example, plastic materials such aspolypropylene, polyethylene, polyglycolic acid, polyurethane, or athermoplastic elastomer. The plastic materials may include a pigmentcontrasting with body tissue color to enable better visualization of thefastener during its deployment. Alternatively, the fastener may beformed of a metal, such as stainless steel or a shape memory metal, suchas Nitinol.

As may be further noted in FIG. 10, the connecting member 206 has avertical dimension 228 and a horizontal dimension 230 which istransverse to the vertical dimension. The horizontal dimension issubstantially less than the vertical dimension to render the connectingmember 206 readily bendable in a horizontal plane. The connecting memberis further rendered bendable by the nature of the material from whichthe fastener 200 is formed. The connecting member may be formed fromeither an elastic plastic or a permanently deformable plastic. Anelastic material would prevent compression necrosis in someapplications.

It may be noted in FIGS. 10 and 11, that the first member 202 has acontinuous lengthwise slit 225 extending between the first and secondends 216 and 218. The slit 225 includes an optional slot portion 226that communications with the through channel 212. The slot 226 has atransverse dimension for more readily enabling receipt of a tissuepiercing deployment wire during deployment of the fastener 200. Also,because the fastener number 202 is formed of flexible material, the slit225 may be made larger through separation to allow the deployment wireto be snapped into and released from the through channel 212 as will beseen subsequently. This permits release of the first member 202 duringdeployment. The slit 225 extends substantially parallel to the throughchannel 212 and the center axis 208 of the first member 202. It may alsobe noted that the slit 225 has a width dimension that is smaller or lessthan the diameter of the through channel 212. This assures that thefastener 200 will remain on a tissue piercing deployment wire as it ispushed towards and into the tissue as will be seen subsequently.

Referring now to FIG. 12, it is a perspective view with portions cutaway of a fastener assembly 300 embodying the present invention fordeploying the fastener 200. The tissue layer portions above the fastener200 have been shown cut away in FIGS. 12-16 to enable the deploymentprocedure to be seen more clearly. The assembly 300 generally includesthe fastener 200, a deployment wire 264, a pusher 266, and a guide tube268.

The first member 202 of the fastener 200 is slidingly received on thedeployment wire 264. The deployment wire 264 has a pointed tip 278 forpiercing the tissue layers 180 and 182 to be fastened together and tocut sufficient tissue to enable the fastener member 202 to readily passthrough the tissue layers 180 and 182. It may also serve as a guide toguide the wire 264 off of the member 202 at the end of the deployment.The tissue piercing wire 264, fastener 200, and the pusher 266 are allwithin the guide tube 268. The guide tube 268 may take the form of acatheter, for example, as previously mentioned, or a guide channelwithin a block of material.

As will be further noted in FIG. 12, and according to this embodiment ofthe invention the second member 204 is disposed along side the firstmember 202, with the connecting member between the first member 202 andthe second member 204. The second member 204 also trails the firstmember 202 with respect to the tissue layers 180 and 182. This is allrendered possible due to the flexibility of the connecting member 206.

With the first member 202 of the fastener 200 slidingly received on thetissue piercing wire 264 and with the pusher 266 just touching the firstmember 202 on the tissue piercing wire 264, the tip 278 of the tissuepiercing wire 264 pierces the tissue layers 180 and 182. The subassemblyof the tissue piercing wire 264, fastener 200, and pusher 266 may beguided to its intended location relative to the tissue layers 280 and282 by the guide tube 268.

As shown in FIG. 13, the tissue piercing wire 264 has pierced the tissuelayers 180 and 182 and the pusher 266 has pushed the first member 202 ofthe fastener 200 through the tissue layers 180 and 182 on the tissuepiercing wire 264. This may be accomplished by moving the wire 264 andthe pusher 266 together.

As may be seen in FIG. 14, wire 264 has been pushed further forward andindependently from the first member 202 and the pusher 266. The firstmember 202 has also been pushed forward by the pusher 266 to cause thesecond member 204 to engage the tissue layer 180. Continued pushing ofthe first member 202 causes the first member to pivot in a counterclockwise direction because the second member 204 is held by the tissuelayer 180. The counter clockwise movement of the first member 202 causesthe wire 264 to spread the slit 225 open, to pass down the slit to enterslot portion 226 and to eventually pass through the slit 225 at end 218.The fastener 200 is then released from the wire 264.

In FIG. 15, it will now be seen that the second end 218 of the firstmember 202 has cleared the wire 264 and tissue layer 182. The tissuepiercing wire 264 may now be retracted into the pusher 266 and thetissue piercing wire 264 and pusher 266 may be withdrawn.

FIG. 16 illustrates the fastener 200 in its fully deployed position. Itwill be noted that the fastener has returned to its original shape. Thetissue layers 180 and 182 are fastened together between the first member202 of the fastener 200 and the second member 204 of the fastener 200.The connecting member 106 extends through the tissue layers 180 and 182.

Referring now to FIGS. 17 and 18, FIGS. 17 and 18 illustrate a controlassembly 400 for controlling the delivery and deployment of fastenersaccording to an embodiment of the present invention. More specifically,the assembly 400, according to this embodiment, is adapted to be locatedat the proximal end of an assembly, such as those shown in FIGS. 5-9 and12-16 for deploying fasteners into stomach tissue for maintainingmanipulated stomach tissue which has been folded and molded to restore aGEFV flap.

The assembly 400 generally includes a housing 402. The housing includesidentical, side-by-side control assemblies 404 and 406. Since thecontrol assemblies 404 and 406 are identical, only assembly 404 will bedescribed in detail herein.

The assembly 404 includes a bolt 410, a receiver 412 that slidinglyreceives the bolt 410 and the pusher 266. Projecting from the bolt is ahandle 414. The handle extends through a track 416 in the housing 402and restricts and measures the movement of the bolt 410.

As previously mentioned, the control assemblies 404 and 406 areside-bi-side and identical. Hence, the assembly 406 may also be seen toinclude a bolt 510, a pusher 366, a receiver 512, and a handle 514projecting through a track 516. The operation of the assembly 406 isidentical to the operation of the assembly 404 to be describedsubsequently.

The assembly 404 still further includes a fastener loading station 420.The loading station 420 has a length dimension 422 sufficient to receivea fastener loader to be described subsequently with respect to FIG. 20.The fastener loader and loading station facilitate loading of fastenersonto the deployment stylet 264. The assembly 406 also includes such aloading station 520.

As may be best seen in FIG. 18, the bolt 410 of assembly 404 is attachedto the proximal end of the stylet 264. Hence, the bolt and stylet arearranged for linear movement when the bolt 410 is moved within thereceiver 412 with the handle 414 along the track 416.

The pusher 264 intersects the path of the stylet 264 at an intersectionpoint 418. The pusher, as best described in copending application Ser.No. 11/043,903, includes an opening at the intersection 418. The openingpermits the stylet to be fed into the pusher and hence to allow thepusher 266 to be carried by the stylet 264 distal to the intersection418. As previously seen, this permits the pusher 266 to engage thefastener 200. Also, the loading station 420 is distal to theintersection 418 to permit the fastener 200 to be loaded onto the stylet264 and engaged by the pusher 266.

The bolt 410 further includes a lumen 411 that slidingly receives thepusher 266. This permits the movement of the pusher 266 to be controlledindependently of the movement of the bolt 410 and the stylet 264. Thebolt 510 also includes such a lumen 511 as may be seen in FIG. 17.

As may be further noted in FIG. 18, the assembly 404 further includes afastener configuration structure 428 including a funnel shaped wall 430between the loading station 420 and the guide lumen 269. As may berecalled from FIGS. 12-16, the guide lumen 269 guides the stylet 264,fastener 200, and pusher 266 to the desired location for deploying thefasteners. The funnel shaped wall 430 serves to preposition the secondmember 204 of the fastener 200 within the guide lumen 269 as best seenin FIG. 12. The second member 204 is prepositioned as a trailing memberalong side the first member 202 with the connecting member 206therebetween. This fastener configuration and prepositioning assists inthe proper functioning of the second member 204 as the fastener 200 isdeployed. The second member 204 is automatically rendered in itspreposition along side the first member 202 with the connecting member206 therebetween as the fastener 200 is translated distally through thefunnel shaped wall section towards the guide lumen 269.

FIG. 19 illustrates this in greater detail. Here we see a fastener 200as it is pushed through the fastener configuration structure 432. As thefastener enters the fastener configuration structure 428, the secondmember 204 of the fastener 200 engages the funnel shaped wall 430. Thefunnel shaped wall 430 guides the second member 204. As the secondmember 204 follows the funnel shaped wall downward, it begins to trailthe first member 202. Also, the connecting member 206 is folded back tobe between the first member 202 and the second member 206 of thefastener 200. As a result, by the time the fastener 200 reaches thefastener configuration outlet 431 communicating with the guide lumen269, the second member 204 is automatically disposed trailing and alongside the first member 202 with the connecting member 206 therebetween.The fastener is now configured for dependable deployment.

When it is time to advance the stylet 264 in through the tissue as shownin FIG. 15, for example, the handle 414 of assembly 400 is moved in adistal direction forcing the stylet 264 to move distally. The handle andthus the stylet movement is restricted and measured by a transverseportion of slot 417 of the track 416. The handle 414 may be locked in alongitudinal position within the transverse portion 417 of the track.The fastener 200 is advanced by the pusher 266. After a fastener isdeployed, the distal end of the pusher is drawn back to be proximal tothe loading station 420 to permit another fastener to be loaded onto thestylet 264.

The fasteners are loaded onto the stylet by presenting the slit 225 ofthe fasteners to the stylet. The slit 225 (FIG. 11) is widened by thestylet 264 and the stylet 264 slips through the slit 225 and into thethrough channel 212 of the fastener first member 202.

FIG. 20 shows a fastener loader 450 which may be employed for loadingthe fasteners onto the stylet. The loader 450 has a handle 452permitting it to be readily hand-holdable. At the distal end, the loaderis arranged to carry a plurality of fasteners 200. The loader presentsthe fasteners so that the slit 225 will be aligned with the stylet 264.

The holder has a width dimension 454 that is less than the lengthdimension 422 (FIGS. 17 and 18) of the loading station 420. Hence, asseen in FIG. 20, the loader 450 may be inserted into a loading stationfor mounting a fastener onto a corresponding stylet. The loader 450 maybe used on either side of the assembly 400 for loading a fastener ontostylet 264 at loading station 420 or loading a fastener onto stylet 364at loading station 520.

While particular embodiments of the present invention have been shownand described, modifications may be made, and it is therefore intendedin the appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention.

1. A fastener assembly comprising: a fastener including a first member,a second member, the first and second members having first and secondends, and a flexible connecting member fixed to each of the first andsecond members intermediate the first and second ends and extendingbetween the first and second members, the first member having alongitudinal axis and a through channel along the axis; a deploymentwire slidingly received within the through channel of the first memberthat pierces into the tissue and guides the first member through thetissue; a guide structure defining a lumen that receives the fastenerand deployment wire and guides the deployment wire and fastener to thetissue; and a fastener configuration structure that orientates thesecond member in a predetermined position relative to the first memberwithin the lumen.
 2. The assembly of claim 1, wherein the fastenerconfiguration structure orientates the second member along side thefirst member.
 3. The assembly of claim 1, wherein the fastenerconfiguration structure orientates the second member along side thefirst member with the connecting member between the first and secondmembers.
 4. The assembly of claim 1, wherein the fastener configurationstructure orientates the second member along side the first member withthe connecting member between the first and second members and with thesecond member trailing the first member with respect to the tissue. 5.The assembly of claim 1, wherein the first member of the fastener has alengthwise slit communicating with the through channel and wherein thedeployment wire is received into the through channel through the slit.6. The assembly of claim 5, further comprising a fastener loader thatguides the first member slit into engagement with the deployment wire.7. The assembly of claim 6, wherein the fastener loader is arranged tohold a plurality of the fasteners.
 8. The assembly of claim 1, whereinthe fastener configuration structure comprises a wall converging withthe deployment wire and an outlet communicating with the lumen.
 9. Theassembly of claim 8, wherein the wall converges with the deployment wirein a direction towards the tissue so that, when the second memberengages the wall, the wall directs the second member to thepredetermined position relative to the first member.
 10. The assembly ofclaim 9, wherein the wall orientates the second member along side thefirst member.
 11. The assembly of claim 9, wherein the wall orientatesthe second member along side the first member with the connecting memberbetween the first and second members.
 12. The assembly of claim 9,wherein the wall orientates the second member along side the firstmember with the connecting member between the first and second membersand with the second member trailing the first member with respect to thetissue.
 13. A fastener assembly comprising: a fastener including a firstmember, a second member, the first and second members having first andsecond ends, and a flexible connecting member fixed to each of the firstand second members intermediate the first and second ends and extendingbetween the first and second members, the first member having alongitudinal axis and a through channel along the axis; a deploymentwire slidingly received within the through channel of the first memberthat pierces into the tissue and guides the first member through thetissue; and a guide structure defining a lumen that receives thefastener and deployment wire and guides the deployment wire and fastenerto the tissue, the second member of the fastener being along side thefirst member with the connecting member between the first and secondmembers within the lumen.
 14. The assembly of claim 13, wherein thesecond member is along side the first member with the connecting memberbetween the first and second members and with the second member trailingthe first member with respect to the tissue.
 15. The assembly of claim14, further comprising a fastener configuration structure thatorientates the second member along side the first member with theconnecting member between the first and second members and with thesecond member trailing the first member with respect to the tissuewithin the lumen.
 16. The assembly of claim 15, wherein the fastenerconfiguration structure comprises a funnel-shaped member having a wallconverging with the deployment wire and an outlet communicating with thelumen.
 17. The assembly of claim 16, wherein the wall converges with thedeployment wire in a direction towards the tissue so that, when thesecond member engages the wall, the wall directs the second member alongside the first member with the connecting member between the first andsecond members and with the second member trailing the first member withrespect to the tissue.
 18. The assembly of claim 17, further comprisinga pusher that pushes the fastener along the deployment wire towards thetissue to cause the second member to engage the wall, to cause the wallto direct the second member along side the first member with theconnecting member between the first and second members and with thesecond member trailing the first member with respect to the tissue, andto cause the fastener to exit the outlet into the lumen as the pusherpushes the fastener along the deployment wire towards the tissue. 19.The assembly of claim 13, wherein the first member of the fastener has alengthwise slit communicating with the through channel and wherein thedeployment wire is received into the through channel through the slit.20. The assembly of claim 19, further comprising a fastener loader thatguides the first member slit into engagement with the deployment wire.21. The assembly of claim 20, wherein the fastener loader is arranged tohold a plurality of the fasteners.
 22. A method comprising: providing afastener including a first member, a second member, the first and secondmembers having first and second ends, and a flexible connecting memberfixed to each of the first and second members intermediate the first andsecond ends and extending between the first and second members, thefirst member having a longitudinal axis and a through channel along theaxis; mounting the fastener onto a deployment wire with the deploymentwire slidingly received by the through channel of the first member;translating the fastener to within a lumen dimensioned to receive thefastener and deployment wire and which guides the deployment wire andfastener to tissue; and orientating the second member in a predeterminedposition relative to the first member as the fastener is translated towithin the lumen. 23-26. (canceled)